Oxcarbazepinedosage

Adult Patients: The recommended initial dosage is 600 mg once per day. Increase the dosage in weekly increments of 600 mg once per day, based on clinical response and tolerability, to a recommended maintenance dosage of 1200 mg to 2400 mg once per day. In adult patients with a creatinine clearance <30 mL/min, initiate at one-half the usual starting dosage and increase slowly.

Pediatric Patients: The recommended dosage is based on body weight and is administered orally once per day. Increase the dosage in weekly intervals based on clinical response and tolerability, to the recommended dosage.

Geriatric Patients: Start at lower dosage (300 mg or 450 mg/day) and increase slowly. In conversion of oxcarbazepine immediate-release to Oxtellar XR ®, higher dosages of Oxtellar XR may be necessary.

2.1 Important

Administration Instructions Administer Oxtellar XR as a single daily dose taken on an empty stomach (at least 1 hour before or at least 2 hours after meals). If Oxtellar XR is taken with food, adverse reactions are more likely to occur because of increased peak levels. Swallow Oxtellar XR tablets whole. Do not cut, crush, or chew the tablets. For ease of swallowing in pediatric patients or patients with difficulty swallowing, achieve daily dosages with multiples of appropriate lower strength tablets (e.g., 150 mg tablets).

2.2 General

Dosing Recommendations Monotherapy or Adjunctive Therapy Adult Patients Initiate treatment at a dosage of 600 mg/day given orally once daily for one week. Subsequent dosage increases can be made at weekly intervals in 600 mg/day increments to achieve the recommended daily dosage. The recommended daily dosage of Oxtellar XR is 1200 mg to 2400 mg/day, given once daily. The dosage of 2400 mg/day showed slightly greater efficacy than 1200 mg/day, but was associated with an increase in adverse reactions. Dosage adjustment is recommended with concomitant use of strong CYP3A4 enzyme inducers or UGT inducers, which include certain antiepileptic drugs (AEDs). Pediatric Patients (6 to Less than 17 Years of Age) In pediatric patients 6 to less than 17 years of age, initiate treatment at a daily dosage of 8 mg/kg to 10 mg/kg orally once daily, not to exceed 600 mg per day in the first week. Subsequent dosage increases can be made at weekly intervals in 8 mg/kg to 10 mg/kg increments once daily, not to exceed 600 mg, to achieve the target daily dosage. The target maintenance dosage, achieved over two to three weeks, is displayed in Table 1.

Table 1: Target Daily Dosage in Pediatric Patients (6 to Less Than 17 Years of Age) Weight Target Daily Dosage 20 kg to 29 kg 900 mg/day 29.1 kg to 39 kg 1200 mg/day Greater than 39 kg 1800 mg/day Dosage adjustment is recommended with concomitant use of strong CYP3A4 enzyme inducers or UGT inducers, which include certain antiepileptic drugs (AEDs).

2.3 Dosage Modifications in

Adult Patients with Renal Impairment In adult patients with severe renal impairment (creatinine clearance less than 30 mL/minute), initiate Oxtellar XR at one-half the usual starting dosage (300 mg/day). Subsequent dosage increases can be made at weekly intervals in increments of 300 mg to 450 mg/day to achieve the desired clinical response.

2.4 Dosage Modifications in

Geriatric Patients In geriatric patients, consider starting at a lower dosage (300 mg or 450 mg/day). Subsequent dosage increases can be made at weekly intervals in increments of 300 mg to 450 mg/day to achieve the desired clinical effect.

2.5 Dosage Modification with

Concomitant Use of Strong CYP3A4 Enzyme Inducers or UGT Enzyme Inducers Strong CYP3A4 inducers, including enzyme-inducing antiepileptic drugs such as carbamazepine, phenobarbital, and phenytoin, and UGT inducers (e.g., rifampin) decrease exposure to 10-monohydroxy derivative (MHD), the active metabolite. Dosage adjustment of Oxtellar XR may be required after initiation, dosage modification, or discontinuation of such inducers. Dosage increases of Oxtellar XR may be necessary with concomitant use. Consider initiating at 900 mg once daily for adults and 12 to 15 mg/kg orally once daily (not to exceed 900 mg per day in the first week) in pediatric patients.

2.6 Withdrawal of AEDs

As with most antiepileptic drugs, Oxtellar XR should be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

2.7 Conversion from

Immediate-Release Oxcarbazepine to Oxtellar XR In conversion of oxcarbazepine immediate-release to Oxtellar XR, higher dosages of Oxtellar XR may be necessary.